NCT06810778

Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Phase I/II Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, phase I/II study of duvelisib in combination with Venetoclax for patients with relapsed/refractory NHL. Duvelisib is an FDA approved, marketed product used to treat certain patients with leukemia and lymphoma and Venetoclax, which is approved for treatment of certain patients with acute myeloid leukemia. The combination of these two drugs is experimental. Experimental means that it is not approved by the United States Food and Drug Administration (FDA). The researchers want to find out how safe it is to combine these drugs and how well this combination can work for your cancer.

Detailed description

In this phase I/II trial, we combine duvelisib and venetoclax in patients with relapsed/refractory Peripheral T-cell lymphoma (PTCL). Researchers aim to determine the maximum tolerated doses (MTD) of duvelisib in combination with venetoclax, the safety of combination therapy, and preliminary efficacy data in Peripheral T-cell lymphoma (PTCL). Patients with PTCL would be offered the option to remain on treatment beyond 2 years if they are clinically benefitting, complete response, partial response, stable disease (CR, PR, SD). The phase I portion of the trial will determine the dose, schedule, safety, and tolerability of duvelisib in combination with venetoclax. Phase I: In the phase I study, 2 dose levels of duvelisib (15 and 25 mg BID) and 3 dose levels of venetoclax (200, 400, and 800 mg QD) will be evaluated. Patients will start with 15 mg BID of duvelisib and 200 mg QD of venetoclax. We use a traditional 3 + 3 design to accrue patients to each combination cohort. There are 5 possible dosing combinations to be tested, with up to 18 patients planned to be enrolled. Enrollment may stop early based on DLTs. The DLT assessment window is defined as Day 1-21 of Cycle 1 (21 days). De-escalation will occur if unexpected toxicity is observed and both drugs will be reduced for the next lower dosing cohort. Increasing drug dosing levels will be performed in parallel cohorts, each increasing either venetoclax or duvelisib (see Dosing Schema). The following lymphoma subtypes will be excluded due to potential tumor lysis risk: cutaneous T-cell lymphoma (CTCL) and T-cell-prolymphocytic leukemia (TPLL). Patients in the initial dosing cohorts will start at a lower dose of venetoclax than the tested dose in phase 2 trials dose (800 mg QD) and at a lower dose of duvelisib than the recommended phase 2 dose (25 mg BID). Once the RP2D of combination duvelisib plus venetoclax is determined, patients assigned to lower dose levels in the phase I trial will have the option to escalate their duvelisib and venetoclax doses to the RP2D. Planned Phase II (dependent on phase I data and new discussions with AbbVie and Secura Bio): The phase II study will only proceed after discussion of Phase I results with study investigators, DSMB, AbbVie, and Secura Bio and will enroll patients with relapsed/refractory PTCL at the RP2D. Phase II will start once phase I data have been reviewed by AbbVie and Secura Bio, DSMB, and FDA, and proceeding to the next phase has been approved. Study visits will occur weekly through cycles 1-2, once per cycle during cycles 3-7, every 2 cycles from cycle 8-13, and every 3 cycles thereafter.

Conditions

• T-cell-prolymphocytic Leukemia
• Cutaneous T-Cell Lymphoma Refractory

Interventions

Type	Name	Description
DRUG	Duvelisib	15 and 25 mg BID
DRUG	Venetoclax	200, 400, and 800 mg QD

Timeline

• Start date: 2025-05-02
• Primary completion: 2030-06-01
• Completion: 2031-06-01
• First posted: 2025-02-06
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study